Filtration and Purification in the Biopharmaceutical Industry, Third Edition

The third edition of "Filtration and Purification in the Biopharmaceutical Industry" has been expanded to include extensive new material on the critical role of purification and advances in filtration science and technology. It provides state-of-the-science information on all aspects of bioprocessing, including current methods, processes, technologies, and equipment. It also covers industry standards and regulatory requirements for the pharmaceutical and biopharmaceutical industries. The book is an essential, comprehensive source for all involved in filtration and purification practices, training, and compliance.

Format: Paperback / softback
Length: 672 pages
Publication date: 13 June 2022
Publisher: Taylor & Francis Ltd

Since sterile filtration and purification steps are becoming increasingly prevalent and critical within medicinal drug manufacturing, the third edition of Filtration and Purification in the Biopharmaceutical Industry significantly expands its focus with extensive new material on the critical role of purification and advances in filtration science and technology. It provides state-of-the-science information on all aspects of bioprocessing, including the current methods, processes, technologies, and equipment. It also covers industry standards and regulatory requirements for the pharmaceutical and biopharmaceutical industries. The book is an essential, comprehensive source for all involved in filtration and purification practices, training, and compliance. It describes such technologies as viral retentive filters, membrane chromatography, downstream processing, cell harvesting, and sterile filtration.

Features:

Addresses recent biotechnology-related processes and advanced technologies such as viral retentive filters, membrane chromatography, downstream processing, cell harvesting, and sterile filtration of medium, buffer, and end product.

Presents detailed updates on the latest FDA and EMA regulatory requirements involving filtration and purification practices, as well as discussions on best practises in filter integrity testing.

Describes current industry quality standards and validation requirements and provides guidance for compliance, not just from an end-user perspective, but also supplier requirement.

It discusses the advantages of single-use process technologies and the qualification needs.

Sterilizing grade filtration qualification and process validation is presented in detail to gain the understanding of the regulatory needs.

The book has been compiled by highly experienced professionals in the field.

Weight: 1240g
Dimension: 254 x 178 (mm)
ISBN-13: 9781032338286
Edition number: 3 ed